Biological indicator for steam sterilization

self-contained Biological Indicator for Steam Sterilization
Operation Manual
【 Description】
Each tube contains a population of Geobacillus stearotermophilus ATCC 7953 spores soaked on a carrier. It also
has a growth indicator media of purple color contained in the glass ampule and with plastic shell outside.
5×105 cfu~1×106cfu/ Geobacillus stearotermophilus ATCC 7953 spores are contained per vial.
【 Usage】
Monitoring Steam Sterilization processes at 121ºC and 134ºC.
【 Instructions】
1,Identify the indicators by writing necessary issues using oil marker on the blank area of the label.(eg: processing
date,load number etc.)
2,Put the indicators horizontally on the places that may occur incomplete sterilization in the sterilizer.
3,After the sterilization has finished,open the sterilizer door and take out the indicators.Check that chemical
indicator printed on the label of the biological indicator has changed to yellow from purple.Keep the indicators
cool down to room temperature for 15 minutes.
4,Break the ampoule contained within the biological indicator using an ampoule crusher.Make sure the paper
adsorbed with spore are in contact with the medium culture.Then be ready to incubate in time.
5,Put the biological indicators vertically into the incubator at temperature 56℃ ~60℃ .Use a non-sterilized
biological indicator as a positive control every time processed Indicators are incubated.
6,Pick off the label and stick it onto the notebook for file after sterilization result has been confirmed.
【 Determination】
1,If color of the medium culture changes to yellow from purple,then it shows positive and indicates failure in the
sterilization process.In this case,please sterilize again.
If color of medium culture keep the same as before,it shows negative and indicates effective sterilization process.
2,For results to be valid, the indicator used as positive control must yield positive (change to yellow from purple).
【 Attention】
1,Make sure the products are unbroken and use it before before expiration date.
2,Better stored in the original box under the next conditions: at temperature 4℃ ~10℃ , 30%~70% relative
humidity.Do not store biological indicators near fire extinguisher or other chemical products.
3,Dispose the positive biological indicators and expired ones.

4,Do not continue to incubate after confirmed that spores have reproduced (shows yellow).
【 Expiration Date】 18 months when stored in stipulate conditions

2. CONTRAINDICATIONS FOR USE

Not allowed:

1. Use of Biological Indicators by personnel who have not been instructed in this manual;

2. Use of Biological Indicators for other purposes, as well as for monitoring sterilization processes other than steam;

3. Use of Biological Indicators after the expiration date, as well as indicators with defects and turbidity of the indicator medium;

4. Keep the Biological Indicators in a horizontal position after the activation process;

5. Incubate non-activated SCBIs;

6. Incubate the SCBIs at a temperature regime other than the regime shown in the table in clause 4;

7. Expose the SCBIs to direct sunlight.

3. SIDE EFFECTS

Subject to the conditions of transportation, storage, as well as this manual, there are no side effects.

4. MAIN TECHNICAL CHARACTERISTICS OF THE SELF-CONTAINED BIOLOGICAL INDICATORS AND MODES OF STERILIZATION

The MEDIWISH indicator is self-contained and is a plastic tube with dried spores of test microorganisms at the bottom. A glass ampoule containing a sterile indicator medium is placed inside a plastic test tube. The plastic tube is closed with a cap with holes. A bacterial filter is placed between the cap and the tube, which protects the contents of the indicator from contamination, but does not prevent the penetration of the sterilizing agent. A class 1 chemical indicator is applied to the label with the indicator marking, which makes it possible to distinguish sterilized biological indicators from indicators not processed in a sterilizer.

NOTES:

* In accordance with ISO 11138-1 and ISO 11138-3, other strains or microorganisms with equivalent properties can be used as test microorganisms.

** It is allowed to produce indicators with a different number of spores on the carrier, provided that the functional properties of the indicators do not deteriorate.

*** It is allowed to produce indicators with a different color of indicator media, subject to a contrasting change in their color during germination of microorganisms during the incubation time indicated in the table.

All permissible changes in the technical characteristics of the indicators indicated above will be reflected in the passport for each batch of indicators

5. COMPLETENESS

1. MEDIWISH indicator – 24 pcs.

2. Plastic breaker – 1 pc.

3. Instructions for use – 1 pc.

4. Consumer packaging – 1 pc.

6. CONTROL

Control over the effectiveness of the sterilization process is carried out by responsible persons within the framework of production control, as well as by authorized representatives of bodies exercising state sanitary and epidemiological supervision in accordance with regulatory documents.

7. ORDER OF APPLICATION

1. Before use, it is necessary to check the expiration date of the indicators, the integrity of the plastic tube, glass ampoule and bacterial filters. Expired and defective indicators are unusable. Each indicator is for one-time use.

2. Indicators must be numbered before placing them in the sterilizer chamber.

3. The laying of indicators in the chamber of the steam sterilizer (the number of indicators and the layout of the control points) during control is carried out in accordance with the requirements of regulatory documents.

4. After sterilization, each indicator is removed from the sterilization chamber and cooled to room temperature for 10 minutes. An indicator that is not sterilized is used as a control.

5. Indicators are activated at the end of the sterilization cycle (but not more than 3 days after the end of sterilization).

6. To activate the indicator, its lower part is placed in the recess of the breaker. Holding the indicator in a vertical position with the cap facing up, using a breaker crush the ampoule with the indicator medium. The activation procedure is carried out for each indicator, including the control one.

7. Incubation of activated indicators is carried out at a temperature of (55 ± 2) ° C. Accounting for the results of biological control is carried out by periodic visual inspection of indicators within 48 hours.

8. INTERPRETATION OF RESULTS

1. The initial indicator medium has a blue-violet color. A change in the color of the indicator medium to yellow of at least one activated indicator processed in the sterilizer indicates the growth of microorganisms and shows that the spores of microorganisms did not die during steam sterilization, therefore, the sterilization cycle does not provide the required sterilization efficiency.

2. Preservation of the initial blue-violet color of the indicator medium of all indicators processed in the sterilizer indicates the provision of the required efficiency of steam sterilization.

3. The results of the control by indicators are correct only if the color of the indicator medium of the control indicator (not processed in the steam sterilizer) changes to yellow after activation.

4. The results obtained must be recorded in the Journal of the accounting statistical form.

5. In case of germination of spores of test microorganisms of at least one indicator processed in a steam sterilizer, the control results are considered negative. In this case, the operation of the steam sterilizer must be suspended until the cause (s) of the violation of the sterilization conditions are clarified and eliminated. Subsequent operation of the sterilizer is allowed only after the steam sterilizer has been tested for the effectiveness of air removal from the sterilization chamber using a test package

“Bowie-Dick”, or “Helix-test”, and repeated control of the sterilization efficiency using biological indicators.

9. DISPOSAL

1. Indicators are safe for humans and animals, do not require special safety measures.

2. Indicators that have given germination of spores of test microorganisms, expired and unusable, before disposal must be subjected to steam treatment with open plugs in steam sterilizers at a pressure of 150 kPa (0.15 MPa) and a temperature (126 ± 2) °С for 90 +5 minutes or 200kPa (0.2 MPa), 134 + 3 °C for 35 + 3 minutes. After the performed procedure, the above indicators, as well as indicators that did not give rise to the growth of spores of test microorganisms (without color change), are disposed of as class “A” safe medical waste.

10. TRANSPORTATION AND STORAGE

10.1. Transportation of indicators can be carried out by any type of closed transport, in

Compliance with the rules for the carriage of goods in force for this type of transport. about

10.2. It is necessary to store indicators in a closed room at a temperature from + 5 ° С to + 30 ° С and a relative humidity of no more than 80%. Do not expose the indicator to direct sunlight. The manufacturing date of the indicator is indicated on the packaging.

11. GUARANTEED STORAGE LIFE

The guaranteed shelf life of indicators is 24 months if the storage and transportation conditions are observed.